Shanghai, China, May 31, 2020 – Shanghai Henlius Biotech, Inc. (2696.HK) and Accord Healthcare Limited (Accord) jointly announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorisation for biosimilar HLX02 (trastuzumab for injection), for the treatment of HER2 positive early breast cancer, HER2 positive metastatic breast cancer and previously untreated HER2 positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction. According to the EMA CHMP summary of positive opinion，HLX02 is highly similar to the reference product Herceptin (trastuzumab). Data show that HLX02 has comparable quality, safety and efficacy to Herceptin.
HLX02 is a biosimilar monoclonal antibody (mAb), that was developed and manufactured by Henlius in accordance with biosimilar guidelines, and will be distributed and marketed across Europe by Accord. The CHMP’s opinion will now be reviewed by the European Commission (EC), with a regulatory decision anticipated in the next 2-3 months. Once approved, a centralised marketing authorisation will be granted for all EU Member States, Iceland, Norway and Liechtenstein.
Dr. Scott Liu, co-founder and CEO of Henlius, said, “We are very proud to receive CHMP positive opinion for HLX02 and that Henlius’ quality in the development and manufacture of biologics has been recognized by an international drug regulatory agency. We look forward to launching HLX02 to provide an alternative high-quality and affordable treatment option for patients with HER2 positive breast cancer and gastric cancer. We will continue to work with Accord to improve the accessibility of HLX02 in Europe and other regions and strive to benefit patients all over the world.”
Dr. James Burt, Executive Vice President, Accord, Europe and MENA said, “We are committed to ensuring oncology patients get access to safe, cost effective medicines and this CHMP positive opinion builds on our established expertise and extensive oncology treatment portfolio. Our agreement with Henlius reflects our strategy of long-standing commitment to biopharmaceutical development, research and manufacturing.”